Bioelectrochemical regenerator and stimulator devices and methods for applying electrical energy to cells and/or tissue in a living body

ABSTRACT

Electrical medical devices and methods are disclosed for the therapeutic treatment of cells and/or tissue in a living body. The electrical medical devices and methods of the invention are useful in the therapeutic treatment of cells and/or tissue which require a &#39;&#39;&#39;&#39;bioelectrical signal&#39;&#39;&#39;&#39; to artificially stimulate healing of the cells and/or tissue. The devices and methods of the invention provide for the generation of an undulating electrical signal having a wave-form whose rise time differs from its fall time which when coupled to the living body induces currents at the tissue level which currents in turn produce a voltage at the tissue level that is bipolar with the amplitude and frequency components of one polarity thereof being different from those of the opposite polarity thereof; the voltage that is bipolar effecting the bioelectrical signal at the cellular or tissue level for artificially stimulating healing of the cells and/or tissue.



1. An electrical medical device for artificially stimulating normal bone growth and repair processes in a predetermined zone of a living body by modifying the electrical potential of the predetermined zone of the living body comprising: a. means for generating an electrical signal undulating in both the positive and negative directions and having a wave-form whose rise time is different from its fall time; and b. means for reactively coupling said signal to said predetermined zone of said living body and for effecting a voltage in said predetermined zone undulating both in the positive and negative directions with the maximum amplitude of said voltage in one direction being greater than the maximum amplitude of said voltage in the opposite direction thereby to artificially stimulate normal bone growth and repair processes in said predetermined zone.
 2. An electrical medical device for artificially stimulating normal bone growth and repair processes in a predetermined zone of a living body by modifying the electrical potential of the predetermined zone of the living body comprising: a. means for generating an undulating electrical signal having a wave-form whose rise time is different from its fall time; and b. means for reactively coupling said signal to said predetermined zone of said living body and for producing current flow in both the positive and negative directions in said predetermined zone with the magnitude of said current in one direction being greater than in the opposite direction thereby to artificially stimulate normal bone growth and repair processes in said predetermined zone.
 3. An electrical medical device for artificially stimulating normal bone growth and repair processes in a predetermined zone of a living body by modifying the electrical potential of the predetermined zone of the living body comprising: a. means for generating an undulating electrical signal having a wave-form in which the fall time with respect to the rise time differs by at least one order; and b. means for reactively coupling said signal to said predetermined zone of said living body and for producing current flow in said predetermined zone whose magnitude in one direction is grEater than in the opposite direction thereby to artificially stimulate normal bone growth and repair processes in said predetermined zone.
 4. An electrical medical device for artificially stimulating normal bone growth and repair processes in a predetermined zone of a living body by modifying the electrical potential of the predetermined zone of the living body comprising: a. means for selectively generating an undulating electrical signal having a wave-form whose rise time widely differs from its fall time and whose rise time corresponds with a high frequency content within the range of from about 10 hertz to about 1 megahertz; and b. means for reactively coupling said signal to said predetermined zone of said living body and for producing by a selected rise time current flow at any selected depth within said predetermined zone whose magnitude in one direction is greater than in the opposite direction thereby to artificially stimulate normal bone growth and repair processes in said predetermined zone.
 5. An electrical medical device for artificially stimulating normal bone growth and repair processes in a predetermined zone of a living body by modifying the electrical potential of the predetermined zone of the living body as set forth in claim 4 wherein said rise time corresponds with a high frequency content within the range of from about 10 hertz to about 10 kilohertz.
 6. An electrical medical device for artificially stimulating normal bone growth and repair processes in a predetermined zone of a living body by modifying the electrical potential of the predetermined zone of the living body as set forth in claim 4 wherein said rise time corresponds with a high frequency content within the range of from about 10 kilohertz to about 50 kilohertz.
 7. An electrical medical device for artificially stimulating normal bone growth and repair processes in a predetermined zone of a living body by modifying the electrical potential of the predetermined zone of the living body as set forth in claim 4 wherein said rise time corresponds with a high frequency content within the range of from about 50 kilohertz to about 200 kilohertz.
 8. An electrical medical device for artificially stimulating normal bone growth and repair processes in a predetermined zone of a living body by modifying the electrical potential of the predetermined zone of the living body as set forth in claim 4 wherein said rise time corresponds with a high frequency content within the range of from about 200 kilohertz to about 1 megahertz.
 9. An electrical medical device for artificially stimulating normal bone growth and repair processes in a predetermined zone of a living body by modifying the electrical potential of the predetermined zone of the living body comprising: a. means for selectively generating an undulating electrical signal having a wave-form whose rise time widely differs from its fall time and whose rise time corresponds with a high frequency content within the range of about 10 hertz to about 1 megahertz, and in which the repetition frequency of said undulating signal is no greater than the reciprocal of the sum of said rise time and of said fall time; and b. means for reactively coupling said signal to said predetermined zone of said living body and for producing by a selected rise time current flow at any selected depth within said predetermined zone whose magnitude in one direction differs from that in the opposite direction thereby to artificially stimulate normal bone growth and repair processes in said predetermined zone.
 10. An electrical medical device for artificially stimulating normal bone growth and repair processes in a predetermined zone of a living body by modifying the electrical potential of the predetermined zone of the living body comprpsing: a. means for generating an undulating electrical signal having a wave-form whose rise time is different from its fall time; and b. means for non-faradaically reactively coupling said signal to said predetermined zone of said living body and for effecting ionic current flow in said predetermined zone whose magnitude in one direction is greater than in the opposite direction thereby artificially stimulate normal bone growth and repair processes in said predetermined zone.
 11. An electrical medical device for artificially stimulating normal bone growth and repair processes in a predetermined zone of a living body by increasing the absolute value of the electrical potential of the predetermined zone of the living body comprising: a. means for generating an undulating electrical signal having a wave-form whose rise time is different from its fall time; and b. means for reactively coupling said signal to said predetermined zone of said living body and for effecting current flow in said predetermined zone whose magnitude in one direction is greater than in the opposite direction and is in direction and of magnitude to establish said increased absolute value of electrical potential thereby to artificially stimulate normal bone growth and repair processes in said predetermined zone.
 12. An electrical medical device for artificially stimulating normal bone growth and repair processes in a predetermined zone of a living body by modifying the local potentials at the membranes of cells and fluid interfaces in the predetermined zone of the living body comprising: a. means for generating an undulating electrical signal having a wave-form whose rise time is different from its fall time; and b. means for coupling said signal to said living body and for effecting a voltage in said predetermined zone of amplitude in one direction greater than in the opposite direction thereby modifying the local potentials at the membranes of cells and fluid interfaces in the predetermined zone thereby to artificially stimulate normal bone growth and repair processes in said predetermined zone.
 13. An electrical medical device for artificially stimulating normal bone growth and repair processes in a predetermined zone of a living body by modifying the local potentials at the membranes of cells and fluid interfaces of the predetermined zone of the living body comprising: a. means for generating an undulating electrical signal having a wave-form whose rise time is different from its fall time; and b. means for reactively coupling said signal to said predetermined zone of said living body and for effecting a current flow in said predetermined zone of magnitude in one direction greater than in the opposite direction which current in turn produces a voltage in the predetermined zone having an amplitude in one direction greater than in the opposite direction, said voltage modifying the local potentials at the membranes of cells and fluid interfaces of the predetermined zone thereby to artificially stimulate normal bone growth and repair processes in said predetermined zone.
 14. The method of artificially stimulating normal bone growth and repair processes in a predetermined zone of a living body by modifying the electrical potential of the predetermined zone of the living body comprising the steps of: a. generating an electrical signal undulating in both the positive and negative directions and having a wave-form whose rise time is different from its fall time; and b. reactively coupling said signal to said predetermined zone of said living body for effecting a voltage in said predetermined zone undulating both in the positive and negative directions with the maximum amplitude of said voltage in one direction being greater than the maximum amplitude of said voltage in the opposite direction thereby to artificially stimulate normal bone growth and repair processes in said predetermined zone.
 15. The method of artificially stimulating normal bone growth and repair processes in a predetermined zone of a living body by modifying the electrical potential of the predetermined zone of the living body comprising the steps of: a. generating an undulating electrical signal having a wave-form whose rise time is different from its fall time; and b. reactively coupling said signal to said predetermined zone of said living body for effecting current flow in both the positive and negative directions in said predetermined zone with the magnitude of said current in one direction being greater than in the opposite direction thereby to artificially stimulate normal bone growth and repair processes in said predetermined zone.
 16. The method of artificially stimulating normal bone growth and repair processes in a predetermined zone of a living body by modifying the electrical potential of the predetermined zone of the living body comprising the steps of: a. generating an undulating electrical signal having a wave-form in which the fall time with respect to the rise time differs by at least one order; and b. reactively coupling said signal to said predetermined zone of said living body for effecting current flow in said predetermined zone whose magnitude in one direction is greater than in the opposite direction thereby to artificially stimulate normal bone growth and repair processes in said predetermined zone.
 17. The method of artificially stimulating normal bone growth and repair processes in a predetermined zone of a living body by modifying the electrical potential of the predetermined zone of the living body comprising the steps of: a. selectively generating an undulating electrical signal having a wave-form whose rise time widely differs from its fall time and whose rise time corresponds with a high frequency content within the range of from about 10 hertz to about 1 megahertz; and b. reactively coupling said signal to said predetermined zone of said living body for effecting by a selected rise time current flow at any selected depth within said predetermined zone whose magnitude in one direction is greater than in the opposite direction thereby artificially stimulate normal bone growth and repair processes in said predetermined zone.
 18. The method of artificially stimulating normal bone growth and repair processes in a predetermined zone of a living body by modifying the electrical potential of the predetermined zone of the living body as set forth in claim 17 wherein said rise time corresponds with a high frequency content within the range of from about 10 hertz to about 10 kilohertz.
 19. The method of artificially stimulating normal bone growth and repair processes in a predetermined zone of a living body by modifying the electrical potential of the predetermined zone of the living body as set forth in claim 17 wherein said rise time corresponds with a high frequency content within the range of from about 10 kilohertz to about 50 kilohertz.
 20. The method of artificially stimulating normal bone growth and repair processes in a predetermined zone of a living body by modifying the electrical potential of the predetermined zone of the living body as set forth in claim 17 wherein said rise time corresponds with a high frequency content within the range of from about 50 kilohertz to about 200 kilohertz.
 21. The method of artificially stimulating normal bone growth and repair processes in a predetermined zone of a living body by modifying the electrical potential of the predetermined zone of the living body as set forth in claim 17 wherein said rise time corresponds with a high frequency content within the range of from about 200 kilohertz to about 1 megahertz.
 22. The method of artificially stimulating normal bone growth and repair processes in a predetermined zone of a living body by modifying the electrical potential of the predetermined zone of the living body comprising the steps of: a. selectively generating an undulating electrical signal having a wave-form whose rise time widely differs from its fall time and whose rise time corresponds wIth a high frequency content within the range of about 10 hertz to about 1 megahertz, and in which the repetition frequency of said undulating signal is no greater than the reciprocal of the sum of said rise time and of said fall time; and b. reactively coupling said signal to said predetermined zone of said living body for effecting by a selected rise time current flow of any selected depth within said predetermined zone whose magnitude in one direction differs from that in the opposite direction thereby artificially stimulate normal bone growth and repair processes in said predetermined zone.
 23. The method of artificially stimulating normal bone growth and repair processes in a predetermined zone of a living body by modifying the electrical potential of the predetermined zone of the living body comprising the steps of: a. generating an undulating electrical signal having a wave-form whose rise time is different from its fall time; and b. non-faradaically reactively coupling said signal to said predetermined zone of said living body for effecting ionic current flow in said predetermined zone whose magnitude in one direction is greater than in the opposite direction thereby to artificially stimulate normal bone growth and repair processes in said predetermined zone.
 24. The method of artificially stimulating normal bone growth and repair processes in a predetermined zone of a living body by increasing the absolute value of the electrical potential of the predetermined zone of the living body comprising the steps of: a. generating an undulating electrical signal having a wave-form whose rise time is different from its fall time; and b. reactively coupling said signal to said predetermined zone of said living body for effecting current flow in said predetermined zone whose magnitude in one direction is greater than in the opposite direction and is in direction and of magnitude to establish said increased absolute value of electrical potential thereby to artificially stimulate normal bone growth and repair processes in said predetermined zone.
 25. The method of artificially stimulating normal bone growth and repair processes in a predetermined zone of a living body by modifying the local potentials at the membranes of cells and fluid interfaces in the predetermined zone of the living body comprising: a. generating an undulating electrical signal having a wave-form whose rise time is different from its fall time; and b. reactively coupling said signal to said living body for effecting a voltage in said predetermined zone of amplitude in one direction greater than in the opposite direction thereby modifying the local potentials at the membranes of cells and fluid interfaces in the predetermined zone thereby to artificially stimulate normal bone growth and repair processes in said predetermined zone.
 26. The method of aritficially stimulating normal bone growth and repair processes in a predetermined zone of a living body by modifying the local potentials at the membranes of cells and fluid interfaces of the predetermined zone of the living body comprising: a. generating an undulating electrical signal having a wave-form whose rise time is different from its fall time; and b. reactively coupling said signal to said predetermined zone of said living body for effecting a current flow in said predetermined zone of magnitude in one direction greater than in the opposite direction which current in turn produces a voltage in the predetermined zone having an amplitude in one direction greater than in the opposite direction, said voltage modifying the local potentials at the membranes of cells and fluid interfaces of the predetermined zone thereby to artificially stimulate control bone growth and repair processes in said predetermined zone.
 27. The method of artificially stimulating normal bone growth and repair processes in a predetermined zone of a living body by modifying the naturally occurring electrical potentiAl of the predetermined zone of the living body comprising the steps of: a. generating an electrical field which rises and collapses in accordance with a preselected frequency with the time period of the rise of the electrical field being different from the time period of the collapse of the electrical field; and b. reactively coupling said electrical field to said predetermined zone for inducing a voltage in said predetermined zone undulating in both the positive and negative directions with the maximum amplitude of said voltage in one direction being greater than the maximum amplitude of said voltage in the opposite direction thereby to artificially stimulate normal bone growth and repair processes in said predetermined zone.
 28. A method for artificially stimulating bone growth in a predetermined zone of a patient, comprising the steps of: a. generating, by an electric circuit, an electrical signal undulating in both the positive and negative directions and having a wave-form whose rise time is difficult from its fall time; and b. reactively coupling said signal to the patient by applying a pair of spaced electrodes, which electrodes are connected to the electric circuit, adjacent to the predetermined zone with one of the electrodes being located closer to the predetermined zone than the other of the electrodes whereby to produce current flow in the predetermined zone both in the positive and negative directions with the magnitude of said current in one direction being greater than in the opposite direction.
 29. A method as defined in claim 28 wherein the electrode being located closer to said predetermined zone is smaller than the other of said electrodes.
 30. A method for artificially stimulating bone growth in a predetermined zone of a patient, comprising the steps of: a. generating, by an electrical circuit, an electrical signal undulating in both the positive and negative directions and having a wave-form whose rise time is different from its fall time; and b. reactively coupling said signal to the patient by applying at least one coil, which coil is connected to the electric circuit, adjacent to the predetermined zone whereby to induce in the predetermined zone a current undulating in both the positive and negative directions with the maximum magnitude of said current in one direction being greater than the maximum magnitude of said current in the opposite direction. 